Pulmonary And Renal Support During Acute Respiratory Distress Syndrome (PARSA)
In patients presenting with the acute respiratory distress syndrome (ARDS), mechanical ventilation with low tidal volume (6 ml/kg predicted body weight) is the current gold standard for supportive care. However, despite a relative low tidal volume, approximatively one third of patients will experienced tidal hyperinflation, a phenomenon known to induce pulmonary and systemic inflammatory response. A further reduction of the tidal volume to 4 ml/kg (PBW) will prevent pulmonary area from tidal hyperinflation. As a result, hypercarbia and respiratory acidosis are commonly observed with such very low tidal ventilation. Extra corporeal CO2 removal is one of a mean to normalize arterial CO2 tension.
Patients with ARDS also frequently develop acute renal failure which may required Renal Replacement Therapy. Some data suggests that starting early the RRT may favor outcome.
The investigators hypothesized that a strategy combining ECCOR and RRT early in the course of patients presenting ARDS and acute renal failure will allow the tidal volume to be further reduced, providing lung protection, while avoiding the arterial CO2 tension to be increased.
For this purpose, the investigators sought to evaluate the safety and efficacy of adding a membranel oxygenator within an hemofiltration circuit, either upstream or downstream of the hemofilter.
|Acute Respiratory Distress Syndrome Acute Renal Failure||Device: Combined ECCOR and RRT||Phase 3|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Safety and Efficacy of Combined Extracorporeal CO2 Removal and Renal Replacement Therapy in Patients With the Acute Respiratory Distress Syndrome and Acute Renal Failure|
- Arterial carbon dioxide reduction [ Time Frame: 20 min ]20 % reduction of arterial carbon dioxide tension after 20 min of combined ECCOR and RRT
- Gas transfer measurement [ Time Frame: 20 min, H1, H6, H12, H24, H36, H48 and H72. ]Measurement of PO2 and PCO2 before and after the membrane oxygenation
- Arterial blood gases [ Time Frame: 20 min, H1, H6, H12, H24, H36, H48 and H72. ]Measurement of arterial blood gases
- carbon dioxide elimination (VCO2) [ Time Frame: 20 min, H1, H6, H12, H24, H36, H48 and H72. ]Measurement of carbon dioxide elimination rate at the ventilator and at the membrane oxygenator
- Respiratory mechanics and hemodynamic parameters [ Time Frame: 20 min, H1, H6, H12, H24, H36, H48 and H72. ]Measurement of respiratory mechanics and hemodynamic parameters
- Safety monitoring [ Time Frame: 20 min, H1, H6, H12, H24, H36, H48 and H72. ]
Continuous measurement of the differential pressure across the oxygenator membrane and across the hemofilter.
Assessment of catheter dysfunction, clotting or disruption of the extra-corporeal circuit, clotting of the oxygenator membrane or of the hemofilter.
Assessment of patient's haemorragic or thrombotic complications.
|Study Start Date:||November 2010|
|Study Completion Date:||June 2015|
|Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Device: Combined ECCOR and RRT
Please refer to this study by its ClinicalTrials.gov identifier: NCT01239966
|Hopital Paul Desbief|
|Marseille, France, 13002|
|Hopital Ambroise Pare|
|Marseille, France, 13006|
|Principal Investigator:||Jérôme Allardet-Servent, MD||Hopital Ambroise Pare|